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Testim (Testosterone) - Warnings and Precautions

 
 



WARNING: SECONDARY EXPOSURE TO TESTOSTERONE

  • Virilization has been reported in children who were secondarily exposed to testosterone gel [see Warnings and Precautions and Adverse Reactions].
  • Children should avoid contact with unwashed or unclothed application sites in men using testosterone gel [see Dosage and Administration and Warnings and Precautions]
  • Healthcare providers should advise patients to strictly adhere to recommended instructions for use [see Dosage and Administration Warnings and Precautions and Patient Counseling Information].
 

WARNINGS AND PRECAUTIONS

Worsening of Benign Prostatic Hyperplasia (BPH) and Potential Risk of Prostate Cancer


  • Patients with BPH treated with androgens are at an increased risk for worsening of signs and symptoms of BPH. Monitor patients with BPH for worsening signs and symptoms.
  • Patients treated with androgens may be at increased risk for prostate cancer. Evaluate patients for prostate cancer prior to initiating and during treatment with androgens [see Contraindications (4)].

Potential for Secondary Exposure to Testosterone

Cases of secondary exposure resulting in virilization of children have been reported in postmarketing surveillance. Signs and symptoms have included enlargement of the penis or clitoris, development of pubic hair, increased erections and libido, aggressive behavior, and advanced bone age. In most cases, these signs and symptoms regressed with removal of the exposure to testosterone gel. In a few cases, however, enlarged genitalia did not fully return to age-appropriate normal size, and bone age remained modestly greater than chronological age. The risk of transfer was increased in some of these cases by not adhering to precautions for the appropriate use of the topical testosterone product. Children and women should avoid contact with unwashed or unclothed application sites in men using Testim [see Dosage and Administration Use in Specific Populations (8.1) and Clinical Pharmacology].

Inappropriate changes in genital size or development of pubic hair or libido in children, or changes in body hair distribution, significant increase in acne, or other signs of virilization in adult women should be brought to the attention of a physician and the possibility of secondary exposure to testosterone gel should also be brought to the attention of a physician. Testosterone gel should be promptly discontinued until the cause of virilization has been identified.

Polycythemia

Increases in hematocrit, reflective of increases in red blood cell mass, may require lowering or discontinuation of testosterone. Check hematocrit prior to initiating treatment. It would also be appropriate to re-evaluate the hematocrit 3 to 6 months after starting treatment, and then annually. If hematocrit becomes elevated, stop therapy until hematocrit decreases to an acceptable concentration. An increase in red blood cell mass may increase the risk of thromboembolic events.

Venous Thromboembolism

There have been postmarketing reports of venous thromboembolic events, including deep vein thrombosis (DVT) and pulmonary embolism (PE), in patients using testosterone products, such as Testim. Evaluate patients who report symptoms of pain, edema, warmth and erythema in the lower extremity for DVT and those who present with acute shortness of breath for PE. If a venous thromboembolic event is suspected, discontinue treatment with Testim and initiate appropriate workup and management [see Adverse Reactions ].

Use in Women

Due to lack of controlled evaluations in women and potential virilizing effects, Testim is not indicated for use in women [see Contraindications and Use in Specific Populations (8.1, 8.3)].

Potential for Adverse Effects on Spermatogenesis

With large doses of exogenous androgens, including Testim, spermatogenesis may be suppressed through feedback inhibition of pituitary follicle-stimulating hormone (FSH) which could possibly lead to adverse effects on semen parameters including sperm count.

Hepatic Adverse Effects

Prolonged use of high doses of orally active 17-alpha-alkyl androgens (e.g., methyltestosterone) has been associated with serious hepatic adverse effects (peliosis hepatis, hepatic neoplasms, cholestatic hepatitis, and jaundice).  Peliosis hepatis can be a life-threatening or fatal complication.  Long-term therapy with intramuscular testosterone enanthate, which elevates blood levels for prolonged periods, has produced multiple hepatic adenomas.  Testim is not known to cause these adverse effects.  Nonetheless, patients should be instructed to report any signs or symptoms of hepatic dysfunction (e.g., jaundice).  If these occur, promptly discontinue Testim while the cause is evaluated.

Edema

Androgens, including Testim, may promote retention of sodium and water. Edema, with or without congestive heart failure, may be a serious complication in patients with preexisting cardiac, renal, or hepatic disease.  In addition to discontinuation of the drug, diuretic therapy may be required.

Gynecomastia

Gynecomastia occasionally develops and occasionally persists in patients being treated for hypogonadism [see Adverse Reactions ].

Sleep Apnea

The treatment of hypogonadal men with testosterone may potentiate sleep apnea in some patients, especially those with risk factors such as obesity or chronic lung diseases.

Lipids

Changes in the serum lipid profile may occur. Monitor the lipid profile periodically, particularly after starting testosterone therapy and after dose increases.

Hypercalcemia

Androgens, including Testim, should be used with caution in cancer patients at risk of hypercalcemia (and associated hypercalciuria). Regular monitoring of serum calcium concentrations is recommended in these patients.

Decreased Thyroxine-binding Globulin

Androgens, including Testim, may decrease concentrations of thyroxine-binding globulins, resulting in decreased total T4 serum concentrations and increased resin uptake of T3 and T4. Free thyroid hormone concentrations remain unchanged, however, and there is no clinical evidence of thyroid dysfunction.

Flammability

Alcohol-based products, including Testim, are flammable; therefore, patients should be advised to avoid fire, flame or smoking until the Testim has dried.

USE IN SPECIFIC POPULATIONS

Pregnancy

Pregnancy Category X [see Contraindications (4)]:  Testim® is contraindicated in pregnant women or in women who may become pregnant.  Testosterone is teratogenic and may cause fetal harm.  Exposure of a fetus to androgens, such as testosterone, may result in varying degrees of virilization.   If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be made aware of the potential hazard to the fetus.

Nursing Mothers

Although it is not known how much testosterone transfers into human milk, Testim is contraindicated in nursing women because of the potential for serious adverse reactions in nursing infants [see Contraindications (4)].

Pediatric Use

The safety and effectiveness of Testim in pediatric patients less than 18 years old have not been established.  Improper use may result in acceleration of bone age and premature closure of epiphyses.

Geriatric Use

There is insufficient long-term safety data in geriatric patients to assess the potentially increased risks of cardiovascular disease and prostate cancer [see Warnings and Precautions].

Renal Impairment

No studies were conducted in patients with renal impairment.

Hepatic Impairment

No studies were conducted in patients with hepatic impairment.

Page last updated: 2014-12-15

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